BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    MDR report key: 11509786 · Received March 17, 2021

    Report

    Report Number
    9617032-2021-00231
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 18, 2021
    Report Date
    February 24, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903666435
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT WAS OBSERVED. THIS IS RECOGNISED TO BE AN AESTHETIC DEFECT WITH NO IMPACT ON THE EFFICACY OF THE TUBE. BD DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO MANUFACTURING. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES HAD DISCOLORED ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "(B)(6) : 21:06:15 (GMT) MATERIAL NO. 366643 BATCH NO. 0240257 IT WAS REPORTED THAT THE TUBE HAD CRYSTALLIZATION IN IT. CUSTOMER CALLED TO REPORT THAT THEY SAW YELLOW CRYSTALLIZATION IN THE TUBE AND SHE WANTED TO KNOW IF THE TUBES ARE STILL GOOD TO USE. LOT NO. 0240257 EXP 08-31-2021 UNKNOWN NUMBER OF TUBES LIKE THIS BUT SHE DOES HAVE SOME TO RETURN. IT WAS NOTICED ABOUT A WEEK AGO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406212 BD VACUTAINER K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 366643 0240257 50382903666435

    Patients

    Seq Age Sex Outcome Treatment
    1